Ostomy attachment

ABSTRACT

An ostomy attachment comprises a flexible annular seal configured to embrace a stoma and a spout that in use is disposed beneath the stoma and configured to collect ostomy output at skin level and direct ostomy output away from the patient and annular seal and into an ostomy bag, in which the flexible annular seal is formed from an absorbent material and the spout is formed from a non-absorbent material. The annular seal may be an open ring comprising at least one mouldable arm that in use can be wrapped at least partially around the patients&#39; stoma.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/088,810, filed Sep. 26, 2018, which is a National Stage ofInternational Application PCT/EP2017/056259, filed Mar. 16, 2017, underPCT Article 21(2) in English; which claims the priority of Great BritainApplication No. 1605516.2, filed Mar. 31, 2016. The contents of theabove-identified applications are incorporated herein by reference intheir entireties.

BACKGROUND TO THE INVENTION

The terms ostomy and stoma are general descriptive terms that are oftenused interchangeably though they have different meanings. An ostomyrefers to the surgically created opening in the body for the dischargeof body wastes. A stoma is the actual end of the small or large bowel orureter that can be seen flush with or protruding through the abdominalwall. The most common specific types of ostomies are: colostomy, where aportion of the colon or rectum is removed and the remaining colon isbrought to the abdominal wall and generally protrudes through theabdominal wall to form a stoma; ileostomy, where a surgically createdopening in the small intestine, at the end of the remaining ileum, isbrought through the abdominal wall to form a stoma; and a urostomy,where a section of the small bowel is surgically removed and relocatedas a passageway for urine to pass from the kidneys to the outside of thebody through a stoma.

A patient with an ostomy can get chemical dermatitis when the outputfrom the stoma comes into contact with the skin around the stoma. Thiscan happen either because there is an area of the skin around the stomaexposed to stoma output (not protected by an ostomy device) or becausethe material that is used to protect the skin starts to absorb the stomaoutput, resulting in breakdown of the material and contact of the outputwith the skin. The most problematic cases are stomas that are notprotruding sufficiently, retracted stomas and stomas that are asymmetricin shape to include loop and end stomas. This can be categorised asstomas that are emptying onto the skin. The requirement to cut a hole inan ostomy bag to exact the shape and size the patients' stoma createsdeficiencies in obtaining an optimum seal. There are ostomy seals on themarket, used to protect the skin around the stoma from stoma output, butthese are generally hydrocolloid materials which are absorbent, andthus, even if they seal/wrap around the stoma fully, they can absorb theoutput from the stoma, and therefore damage the skin.

A further problem with known ostomy attachments is “pancaking”, whichoccurs when ostomy output sits on or around the stoma and fails to dropinto the ostomy bag, causing the ostomy bag to flatten and close, andsubsequent ostomy output to push its way under the flange of the bag,causing chemical dermatitis, unpleasant odour and leaks.

EP0197672 describes a urostomy appliance in a two-part form, namely afirst parts comprising a hydrocolloid adhesive pad that attached to theskin and having a central hole for receipt of a stoma (in which the holeis cut by a patient prior to application of the pad), and a fitting forthe pad having a dome which, upon fitting, sits over the stoma, and anoutlet pipe that is spaced outwardly from the skin. The device has anumber of problems: first, the outlet pipe 34 is spaced from the skinleaving a void area which can be seen in FIG. 2 where ostomy output cancollect and pool; secondly, the dome has a predefined shape having adiameter that is generally greater than the diameter of the hole cut inthe adhesive pad, meaning that ostomy output will necessarily come intocontact with the hydrocolloid adhesive pad, resulting in chemicalbreakdown of the hydrocolloid and contact between the ostomy output andthe users skin; and thirdly, use of the device requires that a user cuta hole in the adhesive pad corresponding to the shape of their stoma.

It is an object of the invention to overcome at least one of theabove-referenced problems.

STATEMENTS OF INVENTION

The invention provides an ostomy attachment comprising an annular sealconfigured to embrace a stoma and a spout that in use is disposedbeneath the stoma and configured to collect ostomy output at skin leveland direct the collected output away from the patient and annular sealand directly into the ostomy bag. The seal and rim of the spout areflexible to facilitate forming a seal around different sized and shapedstoma (for example, the annular seal can be formed from a hydrocolloidmaterial), and the spout is formed from non-absorbent material (forexample a thermoplastic polymer). The annular seal ensures that theattachment conforms closely to the periphery of the stoma, and the spoutensures that ostomy output is directed away from the patient and theannular seal. This helps avoid the mouldable seal material coming intocontact with the ostomy output and being degraded. In addition, thespout reduces the risk of ostomy output in the ostomy bag splashing backonto the area around the stoma, and helps avoid or minimise the problemof “pancaking” and ensures that the bag remains open, even when thepatient is lying down. The non-absorbent spout also provides a surfacefor the user to interact with, which allows less handling of theabsorbent annular seal.

In a first aspect, the invention provides an ostomy attachmentcomprising an annular seal configured to embrace a stoma and a spoutthat in use is disposed beneath the stoma and configured to directostomy output away from the patient and annular seal and into the ostomybag. The invention also provides an ostomy attachment kit for assemblingan ostomy attachment of the invention, the kit comprising a plurality ofannular seals, each configured to embrace a stoma, and at least onespout configured for attachment to an internal rim of the seal andconfigured to direct ostomy output away from the patient and annularseal and into the ostomy bag during use.

In one embodiment, the annular seal is flexible. In one embodiment, theannular seal comprises (or is formed from) a mouldable material. In oneembodiment, the annular seal comprises (or is formed from) an absorbentmaterial. In one embodiment, the annular seal comprises (or is formedfrom) a hydrocolloid material. The use of a flexible seal avoids theneed for the user to cut a hole in an adhesive pad, as required inEP0197672, and allows simple and accurate adjustability of the sealaround the stoma. In addition, it allows for size adjustment duringpost-surgical edema reduction, or other sizing or shape changes thatoccur, resulting in a more secure seal.

In one embodiment, the spout comprises (or is formed from) anon-absorbent material. Examples of non-absorbent materials includesilicone, polyurethane, or thermoplastic polymers. In one embodiment,the non-absorbent material is non-absorbent to ostomy output, inparticular faecal matter. In one embodiment, the spout is flexible, inparticular sufficiently flexible to allow it to be deformed by the bagso that the spout does not prevent the bag being attached to the annularseal.

In one embodiment, the spout is a low-profile spout. This means that thespout generally does not protrude more than 6 mm

In one embodiment, the spout comprises a partially annular inner rimportion configured to engage with a rim portion of the annular seal, inwhich the partially annular inner rim portion of the spout is flexibleto allow it to conform to a non-uniform stoma.

In one embodiment, the partially annular inner rim of the spout is thinand optionally angled to optimise collection of ostomy output anddelivery of ostomy output directly into an ostomy bag.

In one embodiment, the annular seal is a complete ring, and resilientlydeformable to enable the ring to conform to different sized and shapedstomas.

In another embodiment, the annular ring is an open ring having an upperpart comprising at least one, preferably two, arms configured forin-situ moulding around a patients' stoma, and a lower part comprisingthe spout.

In one embodiment, the spout comprises an at least partially annularring configured for engagement with the internal rim of the annularseal.

In one embodiment, an underside of the spout comprises a partiallyannular slot configured for sealing engagement with part of the ostomybag, preferably a rim of an ostomy bag aperture.

In one embodiment, the spout is detachably attached to the annular seal.This allows the ostomy attachment to be provided in a modular format,where a user can choose from a plurality of annular seals, for exampleto pick a seal formed from a hydrocolloid material that suits the user'sskin. It also allows a user choose from a plurality of different spouts.

The invention also provides an ostomy bag kit comprising an ostomy bagand an ostomy attachment according to the invention.

The invention also provides a method for attaching an ostomy bag to apatient with a stoma, which method employs an ostomy bag having anaperture for receipt of ostomy output, and an ostomy attachmentaccording to the invention. Typically, the method comprises placing theostomy attachment on the patient such that the annular seal at leastpartially and ideally fully surrounds the patients' stoma and the spoutis disposed below the patients' stoma, and preferably attaching theostomy bag to the ostomy attachment and/or patient such that the spoutprojects into the aperture of the bag.

In one embodiment, the annular seal is an open ring in which the openring comprises at least one mouldable arm that in use can be wrapped atleast partially around the patients' stoma. Typically, the methodcomprises the additional step of moulding the at least one mouldable armaround at least part of the patients' stoma.

In one embodiment, the annular skin abutting plate has an upper partcomprising two mouldable arms configured for in-situ adjustment to fullyembrace the patients' stoma. The method typically comprises theadditional step of moulding the two mouldable arms around the patients'stoma.

In one embodiment, an underside of the spout comprises a partiallyannular slot configured for engagement with part of the bag, typicallypart of a rim of the aperture of the ostomy bag, in which the step ofattaching the bag to the ostomy attachment typically includes a step ofengaging the rim of the aperture of the bag with the slot on theunderside of the spout.

Hydrocolloid materials are typically used against the skin to secureostomy bags around stomas. This material can, upon removal, peel offlayers of skin, causing skin complications in people with stomas.Hydrocolloids can take some time to adhere correctly to the skin—theyhave to be warmed up and held to the skin for some time before stickingsecurely. Ostomy devices are typically disposable, single-use devices.As such, patients can run up quite a large bill when repeatedlyreplacing devices.

Accordingly, in a further aspect, the invention provides a modulartwo-part fixing plate comprising a reusable outer ring and a disposableinner ring having an aperture, and in which the inner and outer ringsare configured for removable engagement. In one embodiment, the outerring comprises a hypoallergenic skin-safe adhesive. In one embodiment,the inner ring comprises a mouldable, preferably absorbent, material.

The fixing plate is primarily intended for attaching an ostomy bag.However, other applications may include use as a wound dressing (wherethe inner ring is replaced regularly), or as a means of managingfistulas or attaching fistula bags to fistulas.

In particular, the modular two-part fixing plate comprises: a reusableouter ring having a skin-abutting side comprising a hypoallergenicskin-safe adhesive and a protecting layer on the outer side. Thenon-reusable inner ring is configured for removable engagement withinthe outer ring and typically comprises an annulus formed of a mouldable,preferably absorbent, material with a central aperture configured in oneembodiment to embrace a stoma during use and optionally a peripheralannular housing configured to support the mouldable absorbent annulusand in one embodiment provide a landing site for an ostomy bag.

In one embodiment, the hypoallergenic skin-safe adhesive is siliconeadhesive. In one embodiment, the mouldable absorbent material is amouldable hydrocolloid material.

In one embodiment, the inner circumference of the outer ring and theouter circumference of the inner ring comprise complimentary formationsconfigured for removable inter-engagement between the outer and innerrings. In one embodiment, the formations are shoulders configured forinter-engagement. Other types of formations suitable for providingremovable inter-engagement between the inner and outer rings arepossible and will be apparent to a person skilled in the art.

In one embodiment, the outer and inner rings are configured such thatwhen assembled the skin-abutting side of the inner ring is substantiallyflush with the skin abutting side of the hydrocolloid annulus.

In one embodiment, the outer and inner rings are configured such thatwhen assembled the outer protecting layer of the outer ring issubstantially flush with the landing site for the ostomy bag.

In one embodiment, the support housing is an annular layer of materialthat is disposed on top of the hydrocolloid annulus and includes acircumferential flange that extends beyond the external periphery of thehydrocolloid annulus.

In one embodiment, the outer surface of the peripheral annular housingcomprises a polymer material suitable for engagement with a stoma bag.Examples of suitable material include polyurethane and thermoplasticelastomer.

In one embodiment, an inner circumference of the outer ring comprises amaterial that is harder than the hypoallergenic skin-safe adhesive. Thismay be a hardened polymer such as polyurethane or thermoplasticelastomer or cured silicone. The purpose of the hardened innercircumference is to give structure to the inner ring.

In one embodiment, the non-reusable inner ring comprises a peripheraltab to facilitate separation of the inner ring from the outer ring.

In one embodiment, the reusable outer ring comprises a peripheral tab tofacilitate separation of the outer ring from the users' skin. In oneembodiment, the outer ring comprises two peripheral tabs, typicallydisposed on diametrically opposite sides of the outer ring.

The invention also provides an ostomy bag kit comprising a plurality ofostomy bags, a plurality of non-reusable inner rings, and at least onereusable outer ring.

The invention also provides a method of using a modular two-part fixingplate according to the invention comprising the steps of attaching themodular two-part fixing plate to a users' skin such that the centralaperture of the annulus embraces the users' stoma, attaching an ostomybag to the peripheral annular housing of the inner ring of the two-partfixing plate, using the ostomy bag for a period of time, removing theinner ring and ostomy bag together leaving the reusable outer ringin-situ, attaching a replacement inner ring to the outer ring such thatthe central aperture of the hydrocolloid annulus embraces the users'stoma, and attaching a replacement ostomy bag to the peripheral annularhousing of the inner ring.

In another aspect, the invention provides an ostomy attachmentcomprising an absorbent annular seal configured to embrace a stoma andan at least partially annular rim portion that is disposed along atleast a portion of an internal rim of the annular seal that in use isdisposed beneath the stoma and configured to direct ostomy output awayfrom the patient. This embodiment is suitable for use with convex userswith limited bag aperature size expansion. An embodiment of an ostomyattachment according to this aspect of the invention is illustrated inFIGS. 9 and 10.

In one embodiment, the annular seal is flexible. In one embodiment, theannular seal comprises (or is formed from) a mouldable material. In oneembodiment, the annular seal comprises (or is formed from) an absorbentmaterial. In one embodiment, the annular seal comprises (or is formedfrom) a hydrocolloid material.

In one embodiment, the at least partially annular rim portion comprises(or is formed from) a non-absorbent material. Examples of non-absorbentmaterials include silicone, polyurethane, or thermoplastic polymers.

In one embodiment, the at least the partially annular inner rim portionof the spout is flexible to allow it to conform to a non-uniform stoma.

In one embodiment, the at least partially annular rim portion is thinand optionally angled to optimise collection of ostomy output anddelivery of ostomy output directly into an ostomy bag.

In one embodiment, the annular seal is a complete ring, and resilientlydeformable to enable the ring to conform to different sized and shapedstomas.

In another embodiment, the annular ring is an open ring having an upperpart comprising at least one, preferably two, arms configured forin-situ moulding around a patients' stoma.

In one embodiment, the at least partially annular rim portion comprisesan at least partially annular ring configured for engagement with theinternal rim of the annular seal.

In one embodiment, an underside of the spout comprises a partiallyannular slot configured for sealing engagement with part of the ostomybag, preferably a rim of an ostomy bag aperture.

In one embodiment, the at least partially annular rim portion isdetachably attached to the annular seal. This allows the ostomyattachment to be provided in a modular format, where a user can choosefrom a plurality of annular seals, for example to pick a seal formedfrom a hydrocolloid material that suits the user's skin. It also allowsa user choose from a plurality of different rim portions.

The invention also provides an ostomy bag kit comprising an ostomy bagand an ostomy attachment according to the invention.

Other aspects and preferred embodiments of the invention are defined anddescribed in the other claims set out below.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a plan view of an ostomy attachment according to theinvention;

FIG. 2 is a plan view of the ostomy attachment of FIG. 1 attached to apatient and partially embracing a stoma;

FIG. 3 is a sectional side elevational view of the ostomy attachmentattached to a patient of FIG. 2;

FIG. 4 is a sectional side elevational view of an ostomy attachmentwithout a spout attached to a patient;

FIG. 5 is a sectional side elevational view of the ostomy attachment ofFIG. 4 attached to a patient and an ostomy bag attached to the ostomyattachment, showing where stoma output can come into contact with thepatients' skin;

FIG. 6 is a sectional side elevational view of the ostomy attachment ofthe invention attached to a patient and an ostomy bag attached to theostomy attachment showing how output from the stoma is directed awayfrom the patients' skin by the spout;

FIG. 7 is a top plan view of an ostomy attachment according to analternative embodiment of the invention;

FIG. 8 is a side elevational view of the ostomy attachment of FIG. 7;

FIG. 9 is a top plan view of an ostomy attachment according to analternative embodiment of the invention;

FIG. 10 is a side elevational view of the ostomy attachment of FIG. 9;

FIG. 11 is a perspective view of a reusable outer ring forming a firstpart of the modular two-part fixing plate of the invention;

FIGS. 12A is a bottom plan view of the reusable outer ring of FIG. 11and FIG. 12B is a perspective view from below the outer ring of FIG. 11;

FIG. 13 is a perspective view the inner ring forming the second part ofthe modular two-part fixing plate of the invention, showing the external(outward facing) side;

FIG. 14 is a perspective view of the inner ring of FIG. 13, showing theinternal (skin facing) side;

FIG. 15A is a bottom plan view and 15B is a perspective view from belowof the modular two-part fixing plate of the invention showing the innerring of FIG. 13 concentrically engaged within the outer ring of FIG. 11;

FIG. 16A is a top plan view and 16B is a perspective view from above ofthe modular two-part fixing plate of the invention showing the innerring of FIG. 13 concentrically engaged within the outer ring of FIG. 11;

FIGS. 17A and 17B are sectional side elevational and perspective viewsof the modular two-part fixing plate of FIG. 16.

DETAILED DESCRIPTION OF THE INVENTION

All publications, patents, patent applications and other referencesmentioned herein are hereby incorporated by reference in theirentireties for all purposes as if each individual publication, patent orpatent application were specifically and individually indicated to beincorporated by reference and the content thereof recited in full.

Definitions and General Preferences

Where used herein and unless specifically indicated otherwise, thefollowing terms are intended to have the following meanings in additionto any broader (or narrower) meanings the terms might enjoy in the art:

Unless otherwise required by context, the use herein of the singular isto be read to include the plural and vice versa. The term “a” or “an”used in relation to an entity is to be read to refer to one or more ofthat entity. As such, the terms “a” (or “an”), “one or more,” and “atleast one” are used interchangeably herein.

As used herein, the term “comprise,” or variations thereof such as“comprises” or “comprising,” are to be read to indicate the inclusion ofany recited integer (e.g. a feature, element, characteristic, property,method/process step or limitation) or group of integers (e.g. features,element, characteristics, properties, method/process steps orlimitations) but not the exclusion of any other integer or group ofintegers. Thus, as used herein the term “comprising” is inclusive oropen-ended and does not exclude additional, unrecited integers ormethod/process steps.

As used herein, the term “disease” is used to define any abnormalcondition that impairs physiological function and is associated withspecific symptoms. The term is used broadly to encompass any disorder,illness, abnormality, pathology, sickness, condition or syndrome inwhich physiological function is impaired irrespective of the nature ofthe aetiology (or indeed whether the aetiological basis for the diseaseis established). It therefore encompasses conditions arising frominfection, trauma, injury, surgery, radiological ablation, poisoning ornutritional deficiencies.

As used herein, the term “treatment” or “treating” refers to anintervention (e.g. the administration of an agent to a subject) whichcures, ameliorates or lessens the symptoms of a disease or removes (orlessens the impact of) its cause(s) (for example, the reduction inaccumulation of pathological levels of lysosomal enzymes). In this case,the term is used synonymously with the term “therapy”.

Additionally, the terms “treatment” or “treating” refers to anintervention (e.g. the administration of an agent to a subject) whichprevents or delays the onset or progression of a disease or reduces (oreradicates) its incidence within a treated population. In this case, theterm treatment is used synonymously with the term “prophylaxis”.

As used herein, an effective amount or a therapeutically effectiveamount of an agent defines an amount that can be administered to asubject without excessive toxicity, irritation, allergic response, orother problem or complication, commensurate with a reasonablebenefit/risk ratio, but one that is sufficient to provide the desiredeffect, e.g. the treatment or prophylaxis manifested by a permanent ortemporary improvement in the subject's condition. The amount will varyfrom subject to subject, depending on the age and general condition ofthe individual, mode of administration and other factors. Thus, while itis not possible to specify an exact effective amount, those skilled inthe art will be able to determine an appropriate “effective” amount inany individual case using routine experimentation and background generalknowledge. A therapeutic result in this context includes eradication orlessening of symptoms, reduced pain or discomfort, prolonged survival,improved mobility and other markers of clinical improvement. Atherapeutic result need not be a complete cure.

In the context of treatment and effective amounts as defined above, theterm subject (which is to be read to include “individual”, “animal”,“patient” or “mammal” where context permits) defines any subject,particularly a mammalian subject, for whom treatment is indicated.Mammalian subjects include, but are not limited to, humans, domesticanimals, farm animals, zoo animals, sport animals, pet animals such asdogs, cats, guinea pigs, rabbits, rats, mice, horses, cattle, cows;primates such as apes, monkeys, orangutans, and chimpanzees; canids suchas dogs and wolves; felids such as cats, lions, and tigers; equids suchas horses, donkeys, and zebras; food animals such as cows, pigs, andsheep; ungulates such as deer and giraffes; and rodents such as mice,rats, hamsters and guinea pigs. In preferred embodiments, the subject isa human.

The term “modular” as used herein means that the plate is formed fromtwo parts which can attach together and separate as required. Thisfacilitates the plate being formed with a reusable part (outer ring)formed of a material suitable for attaching to the skin, and a seconddisposable part (inner ring) formed from a hydrocolloid absorbentmaterial suitable for shaping to conform to the stoma. The inner ring istypically adapted for engagement with an ostomy bag, thus allowing thebag and inner ring to be removed together. The modular nature of thefixing plate allows a user to fix the reusable outer ring securely inposition, and leave it in situ while allowing multiple changes of theinner ring and ostomy bag. This facilitates ease of use for the user,provides security insofar as the outer ring once in situ does not haveto be removed every time the bag is changed, and avoids mechanicaldermatitis problems associated with repeated removal of hydrocolloidfixing plates. In addition, use of silicone (or another hypoallergenicskin-safe adhesive) ensures immediate adhesion to the skin, providingthe users with a greater sense of security.

The “protecting layer” as referenced above is a material that providesfor handling of the hypoallergenic skin-safe adhesive, and also providesa landing site for the securing the inner ring. In one embodiment, theprotecting later is a fabric or polymer film that ideally the adhesivecures to, for example a polyurethane film or a polyester fabric.

Exemplification

The invention will now be described with reference to specific Examples.These are merely exemplary and for illustrative purposes only: they arenot intended to be limiting in any way to the scope of the monopolyclaimed or to the invention described. These examples constitute thebest mode currently contemplated for practicing the invention.

Referring to the drawings and initially to FIGS. 1 to 4, there is shownan ostomy attachment according to the invention and indicated generallyby the reference numerals 1. The attachment 1 comprises an annular seal4 and a spout 2 formed of a non-absorbent material which is configuredto direct ostomy output away from the annular seal and the users' skin.In more detail, the annular seal 4 in the form of an open ring andhaving a lower part 5 that is attached to the spout 2 and an upper partformed into two mouldable arms 7A, 7B that can be adjusted to embracethe stoma 8. The annular seal comprises an absorbent material forexample a hydrocolloid material which abuts the skin and has an outerface which presents a landing site for a stoma bag.

In more detail, and referring to FIGS. 2 to 4, an inner circumference ofthe annular seal 4 is shaped to form an angled annular shoulder 10, andthe spout 2 comprises a part-annular ring 11 that is angled to engagewith the shoulder 10, fixing the spout to the annular seal and providingthe spout at skin level to optimise collection of ostomy output. Inaddition, an underside of the spout 2 comprises a curved slot 12dimensioned to engage with the bag and guide the bag into engagementwith the attachment A is best seen in FIG. 3, when the attachment 1 isin-situ on a patient embracing a stoma 8, the spout projects downwardlyand outwardly, away from the stoma, thereby directing ostomy output awayfrom the skin and annular seal and into the bag, and also providing anoverhang which prevents ostomy output in the bag splashing back againstthe stoma.

As can be seen in FIGS. 4 and 5, an ostomy attachment without a spout(which are described in the literature) will not prevent splash-back,and will not prevent ostomy output coming into contact with the users'skin at the area marked A. However, even if the seal does initiallyprevent ostomy output coming into contact with the skin, as these knownseals are generally formed of an absorbent hydrocolloid material whichis designed to absorb ostomy output, the ostomy output causes thematerial of the attachment to breakdown, which results in ostomy outputcoming into contact with the skin. The ostomy attachment of theinvention overcomes this problem by providing a spout formed of anon-absorbent material, which is configured to receive output directlyfrom the stoma and direct it away from the skin and the annular seal.Thus, the annular seal is protected from ostomy output, allowing theseal to be formed of an absorbent material, and the spout which isformed on a non-absorbent material does not break down in response tocontact with ostomy output.

FIG. 6 illustrates an ostomy attachment of the invention 1 attached to apatient and an ostomy bag 15 attached to the ostomy attachment 1 forcollection of output from the ostomy bag. The bag 15 has an opening forreceipt of ostomy output and an engagement plate 16 formed of ahydrocolloid material forming a periphery around the opening. Theengagement plate is configured for engagement with the upper surface ofthe annular seal 4 and includes a lower part which is dimensioned toengage with the curved slot 12 on the underside of the spout, whichhelps guide the ostomy bag into engagement with the ostomy attachment.

In use, the attachment 1 is placed against a users' skin partiallyembracing the users' stoma and with the lower part of the skin abuttingplate placed flush against the lower part of the stoma such that thespout is disposed beneath the stoma. The two mouldable arms 7A and 7Bare then adjusted such that they conform to the periphery of the stoma,forming a good seal between the ostomy attachment and the stoma. The bag15 is then attached to the attachment 1 with the lower part of theengagement plate 16 slotting into the curved slot 12.The hydrocolloidmaterial of surface 4 fuses with the hydrocolloid material of theengagement plate, creating a secure attachment.

In the above embodiment, a skin abutting plate having two mouldable armsis described, however it will be appreciated that the plate may insteadhave one single arm which can be moulded around the upper periphery orthe entirety of the stoma. Alternatively, the skin abutting plate may bea closed ring which is dimensioned to fit the users' stoma, or which isadjustable (for example resiliently deformable) to conform to differentsized and shaped stomas. In addition, the spout as described above isformed from a non-absorbent, rubber-like material, however it may beformed from other materials, for example other forms of non-absorbentpolymer, the details of which will be known to a person skilled in theart.

Examples of absorbent materials for use with the present inventioninclude hydrocolloids, hydrogels and other absorbent materials that mayhave applications in the wound care and ostomy industry. Examples ofnon-absorbent materials that may be used with the present inventioninclude polyurethanes, silicones and thermoplastic elastomers.

Referring to FIGS. 7 and 8, a further embodiment of an ostomy attachmentaccording to invention is illustrated in which parts identified withreference to the previous embodiment are assigned the same referencenumerals. In this embodiment, the spout 2 is shorter and has a lowerprofile than the spout illustrated in the previous embodiment (asillustrated in FIG. 8). In addition, the spout is more flexible that theprevious embodiment, and is easily deformable in a direction towards theusers' skin. The use of this embodiment is substantially the same asthat illustrated with reference to the previous embodiment.

The ostomy attachments described above solve some of the problems of theprior art devices by providing a non-absorbent spout having an inlet atskin level (by virtue of the angled rim), that collects ostomy output atskin level and diverts it away from the users' skin and the annularseal. When the annual seal is an absorbent layer, such as ahydrocolloid, this prevents ostomy output coming into contact with theabsorbent material and causing it to break down. In addition, the spouthelps direct the ostomy output away from the skin and seal and into thebag, and the underside of the spout helps prevent ostomy output in thebag splashing back on the stoma and/or seal.

Referring to FIGS. 9 and 10, a further embodiment of an ostomyattachment according to invention is illustrated in which partsidentified with reference to the previous embodiment are assigned thesame reference numerals. In this embodiment, the spout consists of thepartially annular rim portion 11 that engages with an internal rim ofthe seal (as described with reference to the previous embodiment). Theuse of this embodiment is substantially the same as that illustratedwith reference to the previous embodiment.

The ostomy attachment of this embodiment helps with convex bag userswhere the limitations on size expansion of the bag aperature preventsthe use of a large protruding spout.

Referring now to FIGS. 11 to 17, a modular two-part fixing plate for anostomy bag will be described. The fixing plate, which is indicatedgenerally by the reference numeral 20, comprises two parts, namely anouter ring 21 which is reusable (i.e. can be used multiple times anddoes not have to be replaced when an ostomy bag is replaced) and aninner ring 22 which is non-reusable (i.e. it is generally discarded whenan ostomy bag is discarded).

Referring specifically to FIGS. 11 and 12, the outer ring 21 has a skinabutting face 23 comprising silicone material for adhering safely to ausers' skin, a protecting layer of polymer film 24 to which the siliconeis cured for protecting the silicone material and for ease of handling,and an inner periphery comprising a stepped shoulder 25 for engagementwith the inner ring 22. The inner circumference of the outer ring 21comprises a hard plastic or silicone ring 27 which provides structure.Two tabs 28 are provided on the periphery of the outer ring tofacilitate removal of the ring from the users' skin as well asfacilitating positioning the ring on the users' skin.

Referring specifically to FIGS. 13 to 14, the inner ring 22 comprises acentral annulus 30 formed of a mouldable hydrocolloid material having acentral aperture 31 for receipt of a stoma, and a peripheral annularhousing 32 which sits on top of the central annulus and has acircumferential periphery that extends beyond circumferential peripheryof the central annulus, forming a shoulder 33 that is dimensioned forremovable engagement with the stepped shoulder 25 of the outer ring 21.As illustrated in FIG. 14, when the inner and outer rings engage, thebottom face of the hydrocolloid annulus 30 is substantially flush withthe silicone skin-abutting face 23 of the outer ring 21. The annularhousing is formed of polyurethane material, and includes a singleperipheral tab 34 to facilitate separation of the inner ring 22 andouter ring 21.

FIGS. 15 to 17 show the modular two-part fixing plate 1 in an assembledform, with the inner ring 22 engaged with the outer ring 21.

Equivalents

The foregoing description details presently preferred embodiments of thepresent invention. Numerous modifications and variations in practicethereof are expected to occur to those skilled in the art uponconsideration of these descriptions. Those modifications and variationsare intended to be encompassed within the claims appended hereto.

1. A spout for an ostomy attachment that in use is disposed beneath astoma and configured to collect ostomy output at skin level and directostomy output away from the patient and into an ostomy bag, in which thespout is formed from a non-absorbent material.
 2. The spout as claimedin claim 1, wherein the spout is an open spout.
 3. The spout as claimedin claim 1 in which the spout comprises a partially annular inner rimportion configured to engage with a rim portion of a flexible annularseal, in which the partially annular inner rim portion of the spout isflexible to allow it to conform to a non-uniform stoma.
 4. The spout asclaimed in claim 1, in which the partially annular inner rim of thespout is thin and optionally angled to optimise collection of ostomyoutput and delivery of ostomy output directly into the ostomy bag. 5.The spout as claimed in claim 3 in which the annular seal is an openring comprising at least one mouldable arm that in use can be wrapped atleast partially around the stoma.
 6. The spout as claimed in claim 3 inwhich the annular seal comprises two mouldable arms configured forin-situ adjustment to fully embrace the stoma.
 7. The spout as claimedin claim 3 in which the annular seal comprises a closed ring which isresiliently deformable.
 8. The spout as claimed in any preceding claim 3in which the annular seal is formed from an absorbent material.
 9. Thespout as claimed in claim 8 in which the absorbent material is ahydrocolloid material.
 10. The spout as claimed in claim 3 in which thespout covers an external surface of a lower part of the annular seal.11. The spout as claimed in claim 1 in which an underside of the spoutcomprises a partially annular slot configured for engagement with amouth of an ostomy bag.
 12. The spout as claimed in claim 3 in which theannular seal is flexible to allow it to conform to a non-uniform stoma.13. The spout as claimed in claim 3, in which the spout is detachablyattachable to the annular seal.
 14. A method for attaching an ostomy bagto a patient with a stoma, which method employs an ostomy bag having anaperture for receipt of ostomy output, an annular seal, and a spoutaccording to claim 1, the method comprising placing the annular seal onthe patient such that the annular seal at least partially surrounds thepatients' stoma and attaching the spout to the annular seal to providean ostomy attachment, wherein the spout on the ostomy attachment isdisposed below the patients' stoma, and attaching the ostomy bag to theostomy attachment.
 15. The method as claimed in claim 14 in which theannular seal of the ostomy attachment is an open ring in which the openring comprises at least one mouldable arm that in use can be wrapped atleast partially around the patients' stoma, the method comprising theadditional step of moulding the at least one mouldable arm around atleast part of the patients' stoma.
 16. The method as claimed in claim 14in which the annular seal comprises two mouldable arms configured forin-situ adjustment to fully embrace the patients' stoma, the methodcomprising the additional step of moulding the two mouldable arms aroundthe patients' stoma.
 17. The method as claimed in claim 14 in which anunderside of the spout comprises a partially annular slot configured forengagement with the ostomy bag, in which the step of attaching the bagto the ostomy attachment includes a step of engaging part of the bagwith the slot on the underside of the spout.
 18. A method of attachingan ostomy bag to a patient with a stoma, which method employs an ostomybag having an aperture for receipt of ostomy output, an annular seal,and a spout according to claim 1, the method comprising attaching thespout to the annular seal to provide an ostomy attachment, placing theostomy attachment on the patient such that the annular seal at leastpartially surrounds the patients' stoma and the spout is disposed belowthe stoma, and attaching the ostomy bag to the ostomy attachment. 19.The method as claimed in claim 18 in which the annular seal of theostomy attachment is an open ring in which the open ring comprises atleast one mouldable arm that in use can be wrapped at least partiallyaround the patients' stoma, the method comprising the additional step ofmoulding the at least one mouldable arm around at least part of thepatients' stoma.
 20. A method as claimed in claim 18 in which theannular seal comprises two mouldable arms configured for in-situadjustment to fully embrace the patients' stoma, the method comprisingthe additional step of moulding the two mouldable arms around thepatients' stoma.
 21. A method as claimed in claim 18 in which anunderside of the spout comprises a partially annular slot configured forengagement with the ostomy bag, in which the step of attaching the bagto the ostomy attachment includes a step of engaging part of the bagwith the slot on the underside of the spout.